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US Regulatory Lead, Director- Immunology/Neurology

Company: Principia Biopharma Inc.
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Position Overview:

The US Regulatory Affairs Lead is responsible for the proactive development of innovative and robust US regulatory strategies for pipeline and lifecycle assets in Sanofi's growing immunology and neurology portfolios. He/she will be accountable for the efficient and effective execution of US regulatory strategies while adhering to US regulatory and company guidelines. The US RA Lead will serve as Sanofi's liaison to the US FDA for assigned projects in clinical development. In this role, he/she will lead the strategic development of documentation submitted to the US FDA and lead FDA meetings and negotiations. Further, the role represents the US GRA perspective as a member of the project specific cross functional global regulatory team (GRT). In this capacity, he/she will be accountable to develop and maintain the US regulatory strategy documents and advise on US regulatory issues at internal governance meetings. In addition, the role prospectively works with the labeling strategist and the GRT to develop US prescribing information. The role works with and participates on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products. The role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations. Lastly, the role may supervise and/or coach mentor, junior staff supporting regulatory team.

Key Responsibilities:

  • Strategic thinker with an ability to make complex decisions and willingness to defend difficult positions.

  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance.

  • Demonstrated experience with preparation of initial BLA, NDA, or MAA, INDs, Health Authority meeting briefing documents.

  • Understanding of the development of drugs and/or innovative biologics products.

  • Develops collaborative relationships to facilitate the accomplishment of work goals.

  • Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.

  • Excellent oral and written presentation skills.

  • Direct interaction/negotiation experience with US FDA.

  • Ability to work well within cross-functional globally oriented teams.

  • Excellent time-management and operational skills including planning, organizing and ability to motivate and lead others.

  • Ability to work in electronic document management systems.

  • Ability to build transversal networks to obtain cooperation without relying on authority.

  • High standards of integrity.

  • Organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders.

Basic Qualifications:

  • At least 10 years' experience in drug development.

  • Solid working knowledge of drug development process and US regulatory requirements.

  • Demonstrated success developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs.

  • Experience with drug development in the field of immunology and/or neurology, preferred.

  • Demonstrated experience successfully operating in a global environment.

  • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field, minimum 8 years regulatory strategy experience.

  • Regulatory Certification (RAC) (optional) Fluent English required; additional languages desirable.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Principia Biopharma Inc., Cambridge , US Regulatory Lead, Director- Immunology/Neurology, Other , Cambridge, Massachusetts

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